Singapore banned weight loss pills containing sibutramine
The Singapore Health Science Agency (HSA) has decided to suspend the sale of sibutramine products in the country since October 11.
Sibutramine is marketed in Singapore with four different brands including Reductil®, Ectiva®, Reduxade® and Slenfig®.
The drug was licensed for use in Singapore in 2001 as a supplement to the diet and exercise of obese and overweight patients with fat-related pathogens. Obesity such as type 2 diabetes or lipid metabolism disorders.
Drugs containing sibutramine (Photo: Drsharma)
In a press release released on October 11, the HSA said the decision to suspend the sale of these products was made after it consulted its Drug Advisory Committee (PVAC) and a outside group of experts on metabolic and cardiovascular diseases about the benefits and risks of drugs.
From the benefit-risk assessment of the drug, HSA concluded that increased cardiovascular risk by using sibutramine was greater than the modest weight loss of only 2.4 kg achieved by patients .
The HSA's decision is also based on the Cardiovascular Impact Study of Sibutramine (SCOUT) on the use of products in Singapore, as well as on the research of other international institutions such as the Agency. US Food and Drug Administration (FDA) and European Medicines Agency (EMA).
Study SCOUT is a large study done to assess cardiovascular safety after long-term use of sibutramine in patients with a history of heart disease and / or type 2 diabetes.
Research has shown a serious increase in cardiovascular risk when using sibutramine in patients with pre-existing heart disease.
Meanwhile, in early October 2010, the US Food and Drug Administration (FDA) recommended against continuous use of sibutramine because it may pose unnecessary risks to cardiovascular patients. Earlier, European Medicines Agency (EMA) decided to suspend the marketing of sibutramine throughout Europe.
After the preliminary results of the SCOUT study in early 2010, the HSA updated information for health professionals in January 2010 on cardiovascular risks related to the use of sibutramine and advised experts. Medical should not prescribe medication to patients with a history of heart disease.
All four sibutramine products were not allowed to be used in patients with a history of cardiovascular problems such as coronary artery disease, congestive heart failure, tachycardia, peripheral artery disease, arrhythmia , stroke and high blood pressure.
With the suspension of selling sibutramine, HSA also advises doctors not to prescribe sibutramine to new patients . Patients who have been prescribed sibutramine should consult their doctor to review the treatment.
Patients should also consult their doctor if there are cardiovascular side effects such as increased heart rate, irregular heartbeat, or any other discomfort after taking sibutramine.
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